Three Different Oral Hygiene Regimes on Three Volatile Sulfur Compounds

Halitosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689297
• Other study ID #: OHP-018-EI-2
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2016
• Last updated: February 18, 2016
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2016
• Source: Tokyo Medical and Dental University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the effect of various oral hygiene regimes on three volatile sulfur compounds.

Description:

Thirty male monk volunteers who matched with the including criteria were divided randomly into two groups. Both groups were practiced to brush their teeth with scrubbing method for one week. Then, each group were instructed to do different additional protocol regimen- group A have to do mouth washing and tooth brushing and group B have to practice tongue cleaning addition to tooth brushing for three weeks. At the fifth week, both groups were instructed to practice tooth brushing, mouth washing and tongue cleaning. Three different volatile sulfur compounds were measured by oral chroma. Tongue characteristics, oral examination were checked as the outcomes of this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of oral malodor

• No systemic diseases and no severe dental diseases

• At least 20 functional teeth

Exclusion Criteria:

• Risky oral habit (smoking and betel quid chewing)

• Current use of antibiotics or any drugs

• Current use of any kind of mouthwash

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Halitosis

Intervention

Other:
• chlorine dioxide
First week, subjects were instructed to do regular tooth brushing. After that group A was requested to use chlorine dioxide mouthwash two time per days for three weeks in addition to tooth brushing and then, one week for combination of tooth brushing, tongue cleaning and mouth washing.
• small toothbrush for tongue cleaning
First week, subjects were instructed to do regular tooth brushing. After that group B was requested to brush their tongue with small toothbrush two time per days for three weeks in addition to tooth brushing and then, one week for combination of tooth brushing, tongue cleaning and mouth washing.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical and Dental University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three different volatile sulfur compounds	Investigator measured three different volatile sulfur compounds: hydrogen sulfide, methyl mercaptan, dimethyl sulfide concentrations (ng/10ml) by using Oral chroma.	up to 5weeks	Yes
Secondary	Oral Health examination	As oral examination, investigator examined present teeth, DMF-T (decayed, missing and filled teeth)	up to 5weeks	Yes
Secondary	Tongue coating characteristics	As tongue coating characteristics, investigator examined tongue coating score (by using winkle tongue coating index) at the baseline, one week later, four weeks later and five weeks later.	up to 5weeks	Yes
Secondary	Number of teeth with bleeding on probing		up to 5weeks	Yes
Secondary	Plaque index score		up to 5weeks	Yes